The Recall Desk
HighFDA (Devices)·Z-1566-2022·Announced 2022-08-31

GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport

GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II recall of medical imaging software with measurement accuracy defect. No reported illnesses or injuries. This represents a risk-of-harm product where injury has not yet been reported, per rubric severity score 3 (High).

Plain-English summary

GE Healthcare has recalled three versions of medical imaging software: Centricity Universal Viewer 6.0 (Model 2088026-9XX), Centricity Universal Viewer 7.0 (Model 5826659-0XX), and Universal Viewer 8.0 (Model 5865740-00x). These diagnostic image-viewing applications are used in healthcare settings to display and analyze medical images.

The recalled software versions may produce inaccurate distance and area measurements when the Global Stack viewport feature is used. This measurement inaccuracy could affect the reliability of diagnostic measurements and clinical decision-making by healthcare providers.

Approximately 1,690 devices have been distributed. Distribution includes healthcare facilities throughout the United States and in more than 40 countries worldwide, including Argentina, Australia, Canada, Japan, Mexico, and the United Kingdom, among others.

The recalled product

Product
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
  • measurement-inaccuracy
  • diagnostic-error-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • (1) Centricity Universal Viewer 6.0 - UDI 00840682103800
  • Software versions 6.0 SP9
  • 6.0 SP9.0.1 through 6.0 SP9.0.1.11
  • 6.0 SP9.0.2
  • 00840682145558
  • Software versions 7.0 through 7.0 SP0.0.4.9
  • 7.0 SP0.0.5
  • 7.0 SP0.1.0
  • and 7.0 SP1. (3) Universal Viewer 8.0 - UDI 00195278379610
  • Software versions 8.0
  • 8.0 SP0.1.0
  • and 8.0 SP0.1.1.

Distribution

Distributed in 40 states:

  • AR
  • AZ
  • CA
  • CO
  • DE
  • FL
  • GA
  • IA
  • ID
  • IL
  • IN
  • KS
  • LA
  • MA
  • MD
  • ME
  • MI
  • MO
  • MS
  • MT
  • NC
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • RI
  • SC
  • SD
  • TN
  • TX
  • VT
  • WA
  • WI
  • WV

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